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Several examples of difficulties related to results-based agreements are available in the literature. A Dutch evaluation of a stage III-managed oxaliplatin accession agreement for the treatment of colon cancer based on the results, which collected additional data on a patient registry, showed that patient heterogeneity made it difficult to estimate the incremental cost-effectiveness of treatment based on the data collected (Mohseninejad et al., 2015). A Dutch registry of hematological malignancy indicated that the three main problems were confused due to the indication, lack of data and insufficient number of comparable patients (Blommestein et al., 2015). In Italy, an analysis of 2006-2012 data showed that 67% of expected repayments were actually recovered through certain agreements (Navarria et al., 2015). Among the reasons identified were difficulties related to the required follow-up period, problems with reimbursement notification and insufficient (financial) incentive from the prescribing centre to participate in a program (Garattini et al., 2015); Navarria et al., 2015). These examples underline the crucial importance of robust methods and the clear agreement of upstream stakeholders on the expectations associated with the use of the evidence to be collected. Interviews showed that manufacturers appeared to be more interested in considering the use of results-based agreements than payers. However, European payers and HTA bodies have little appetite for the use of agreements that collect results data because of their complexity. At present, many people remain concerned about standards of evidence for adaptive products (Ermisch et al., 2016; Vella Bonanno et al., 2017). This is a key challenge that needs to be addressed. In the end, patients` access to medicines in the European environment will only be achieved once the products have followed the pricing and reimbursement procedures in the different countries. Without the assistance of HTA bodies and payers in these countries, the introduction of adaptive pathways and viable models for results-based entry-level agreements may be limited. – Financial agreements are easier to implement, but miss the opportunity to use evidence generated after approval.
A possible agreement could combine financial components with a hovering, taking into account the results of new discoveries from TTS, observational studies, registries or electronic medical records; Entry-level managed agreements are agreements between companies and health care recipients that cover new drugs while facing uncertainty about their financial impact or performance. Financial agreements are used in at least two-thirds of OECD and EU member states. Many of these countries also use results-related agreements, which subordinate coverage, business payments or discounts paid by companies to product performance, but these MEAs are less common. With the help of the European Commission, the OECD has reviewed the experience of countries that have adopted performance measures to date to identify best practices and opportunities to use these agreements in the future. Methods used. MEA, Managed Entry Agreement; EUnetHTA, a European health technology impact analysis network; AIM, The international Association of Mutual Benefit Societies; MEDEV, Drug Evaluation Committee; CMA, conditional marketing authorization; ECMA, exceptional circumstances Marketing authorization. Despite the lack of evidence, experience to date with results-based agreements indicates a number of good practices. They cover four main themes: of the 62% of respondents, 25% were devoted to the public sector, the rest to the pharmaceutical (pharmaceutical) industry. Only 42% of participants said that MMAs were making their place in their institutions, with the majority representing Lebanon.
All interviewees reported the use of financial agreements, most of which referred to “updated treatment” and, to a lesser extent, a “price volume agreement”